The latest global regulatory news, changes and updates affecting biopharma, including: Fed Circuit agrees Amgen patents lack enablement; HC nudging along with regulatory modernization plan; EMA: No Sputnik application yet.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinuvel, Genmab, Moderna, Oryzon, Polaryx, Seagen.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atyr, Celltrion, China SXT, Dnatrix, Dyno, Exscientia, Gain, GSK, Incyte, M6P, Macrogenics, Mindmed, Mindshift, Nuvation, Olix, Panacea, Portage, Protalix, Renji, Rentschler, Repertoire, Sandoz, Sarcomed, Vyne.
It’s been more than a year since COVID-19 initially smacked humanity and as BioWorld’s senior analyst, Karen Carey, detailed in early February, vaccine and therapeutic R&D continues to move furiously forward. Variants have added a new twist in the race to gain global control of the virus. But what about tests and surveillance? Are these medical technologies keeping pace with the rapidly changing virus? BioWorld MedTech takes a deep dive in today’s edition.
Staff Writer Meg Bryant looks for answers on whether current tests are effective when it comes to the variants and how the test makers are adapting.
Staff Writer Annette Boyle explores how industry and universities united to scale up surveillance of SARS-CoV-2 variants.
Senior Science Editor Anette Breindl explains why mutations in SARS-CoV-2 are at once a challenge, a fact of life and an opportunity.
Regulatory Editor Mark McCarty highlights how governments are being challenged with keeping track of mutations while simultaneously validating new and revamped existing tests.
Diagnostic manufacturers are turning their attention to antibodies for those who have been vaccinated for the SARS-CoV-2 virus, and the U.S. FDA’s Tim Stenzel had some advice about this on the Feb. 10 testing town hall. Stenzel advised that developers think of such tests in the same vein as a companion diagnostic (CDx) in that these antibody test will have to be separately validated for each vaccine that is included in the test’s labeled claims.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alveo, Cardiacsense, Kantaro, Surgical Planning Associates, Visby.
Under threat of emerging variants, the EU is taking to heart lessons learned so far in the global COVID-19 pandemic to accelerate the review of vaccines, improve data sharing from clinical trials and address the difficulties inherent in the mass production of vaccines that may contain up to 400 components.
Another monoclonal antibody therapy has entered the pandemic fray with the FDA granting emergency use authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg and etesevimab (JS016 or LY-CoV016) 1,400 mg as a cocktail for treating mild to moderate COVID-19 in patients aged 12 and up at high risk for progressing to severe COVID-19 and/or hospitalization.
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